4种门冬氨酸钾镁注射液的质量及生产工艺分析

目的对市售的门冬氨酸钾镁注射液的质量进行评价。方法按照标准对注射剂进行一般项目检查。建立EDTA络合滴定法、原子吸收光谱法、高效液相色谱法的方法分别测定镁离子、钾离子和门冬氨酸。结果一般项目检查结果没有很明显的质量差别,但对钾离子、镁离子和门冬氨酸的含量进行分析后,可发现几种产品工艺上的差别对药物质量产生的影响。结论市售的4种门冬氨酸钾镁注射液的质量存在一定的差异,可能是不同产品的原料及生产工艺的不同所致。

Quality and production technique analysis of four potassium aspartates and magnesium aspartates for injection

AIM To evaluate the quality and production technique of marketed potassium aspartates and magnesium aspartates for injection.METHODS General elementary data inspection of the injection was taken according to the references.Titration with EDTA,atomic absorption spectrum and HPLC were established to determine separately the contents of magnesium ion,potassium ion and aspartic acid.RESULTS No significance was founded in qualing difference in general analysis,but some influences on the pharmaceutical quality due to several different kinds of production technique were found after contents analysis of magnesium ion,potassium ion and aspartic acid.CONCLUSION Some differences existing between the qualities of marketed potassium aspartates and magnesium aspartates for injection,are probably due to the differences of the raw material and production techniques.